FDA Medical Device Recalls (openFDA)
Xoran Technologies, Inc.: Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI
- Recall number
- Z-0826-2008
- Recalling firm
- Xoran Technologies, Inc.
- Product
- Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI
- Status
- Terminated
- Initiated
- 2008-01-04
- Posted
- 2008-02-07
- Terminated
- 2010-10-22
- Reason
- Misbranding; These devices do not bear the manufacturer's name or address.
- Root cause
- Labeling design
- Action
- Consignees were notified via letter, Urgent Medical Device Correction, dated 1/4/08 of the need to apply proper labeling to the products, and were sent instructions and labeling to affix to their units.
- Quantity
- 71
- Distribution
- Nationwide.
- Lot, serial or model codes
- All units
- 510(k) numbers
- ["K032243"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 3004198450
- Firm city
- Ann Arbor
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28